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Clinical Study on Fuzheng Jiedu Huayu Therapy in Combination With Chemotherapy and Immunotherapy for Improving Survival Rates in Extensive-Stage Small Cell Lung Cancer

4 novembre 2026 mis à jour par: LI FENG

Small cell lung cancer (SCLC) is a highly aggressive neuroendocrine malignancy. Approximately 70% of patients are diagnosed with extensive-stage disease, and only a subset of patients benefit from immunotherapy. Under the leadership of Academician Sun Yan, the principal investigator, our research group previously relied on the Big Data Platform of the National Cancer Center and undertook major projects including those from the National Administration of Traditional Chinese Medicine, the Beijing Administration of Traditional Chinese Medicine for collaborative of major and difficult diseases with integrated traditional Chinese and Western medicine, as well as the National Key R&D Program. A randomized controlled trial (RCT) of 600 cases demonstrated that the traditional Chinese medicine "Fuzheng Jiedu Huayu" (strengthening vital energy, detoxifying, and resolving stasis) combined with chemotherapy and immunotherapy synergistically improved progression-free survival and disease control rate in patients with extensive-stage SCLC. Building on this foundation, the current project will enroll 224 patients with extensive-stage SCLC (1:1 ratio). On the basis of first-line treatment with immunotherapy plus platinum-based agents and etoposide, patients will be administered either "Fuzheng Jiedu Huayu" traditional Chinese medicine or a placebo. The study will employ objective response rate, progression-free survival, and overall survival as outcome measures, conducting a multicenter, large-sample RCT. Additionally, a multimodal database of no less than 1000 cases will be established, striving to obtain an IND approval, thereby contributing to the realization of the goal set forth in the "Healthy China 2030" Planning Outline: "By 2030, increase the overall 5-year cancer survival rate by 15%."

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

224

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Chine
      • Beijing, Chine, 100700
        • National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
    • Beijing Municipality
      • Beijing, Beijing Municipality, Chine, 100021
        • National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
    • Chaoyang
      • Beijing, Chaoyang, Chine, 100021
        • Cancer Hospital, Chinese Academy of Medical Sciences/Peking Union Medical College

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  1. Meets the diagnostic criteria for ES-SCLC by pathology and imaging, as well as the diagnostic criteria of Traditional Chinese Medicine for Kidney Deficiency and Vital Essence Depletion with Stasis-Toxin Stagnation.
  2. No prior Western medical anti-tumor therapy, with evaluable lesions;
  3. Planned to receive at least 2 cycles of immunotherapy + platinum + etoposide regimen.
  4. Age 18 years or older, with an expected survival of ≥3 months;
  5. No history of other prior primary malignancies or malignancy merging.
  6. Karnofsky performance status score ≥ 60;
  7. Normal cognitive function and able to cooperate in completing the questionnaire;
  8. Voluntarily accept the treatment regimen of this study and sign the informed consent form.

Exclusion Criteria:

  1. Pregnant or lactating women, or patients with severe diseases of the heart, lung, liver, kidney, blood, or other systems;
  2. Participants in other clinical trials.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Treatment group(Yishen Qutong Granules)

Yishen Qutong Granules administered at 10g per dose, three times daily, in conjunction with immunotherapy plus etoposide and platinum-based first-line treatment.
Médicament: Yishen Qutong Granules

The patent prescription of Professor Feng Li, the head of the Department of Traditional Chinese Medicine at the Cancer Hospital of the Chinese Academy of Medical Sciences.
Comparateur placebo: Control group(Placebo)

In parallel with immunotherapy plus etoposide and platinum-based first-line treatment, administer a simulated formulation of Yishen Qutong Granules (1/10 Yishen Qutong Granules), 10g per dose, three times daily.
Médicament: Yishen Qutong Simulant Granules

Yishen Qutong Simulant Granules is a preparation with one-tenth the dosage of Yishen Qutong Granules.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Objective Response Rate, ORR
Délai: The patient underwent a chest CT scan every two treatment cycles to evaluate antitumor efficacy.

Objective response rate = (complete response + partial response) / total number of patients × 100%.
The patient underwent a chest CT scan every two treatment cycles to evaluate antitumor efficacy.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Numerical Rating Scale
Délai: Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement

The NRS scoring method divides pain into 10 levels, using a scoring range of 0-10. Patients need to choose a level based on their own feelings to represent their pain intensity. The specific classifications are as follows: Grade 0: indicates no pain or no symptoms. Grades 1-3: indicate mild pain, usually not affecting sleep. Grades 4-6: indicate moderate pain, sleep may be affected. Grades 7-10: indicate severe pain, seriously affecting sleep and quality of life.
Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
QLQ-C30 scale point
Délai: Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement

The EORTC QLQ-C30 is a 30-item questionnaire evaluating cancer patients' quality of life across multiple dimensions, including physical, emotional, cognitive, and social functioning, as well as symptom burden (e.g., fatigue, pain, nausea). Scores range from 0 to 100, with higher scores in functional scales and global health status indicating better quality of life, and higher scores in symptom scales indicating worse symptoms.
Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
Overall Survival, OS
Délai: On days 43, 90, 133, 233, 365, 450 and 540 following the commencement of treatment.

The period from the commencement of treatment until the patient's death from any cause.
On days 43, 90, 133, 233, 365, 450 and 540 following the commencement of treatment.
Cancer-related fatigue state
Délai: Before treatment commencement, and at 21 days, 43 days, and 90 days after.

Assessment was conducted using the BFI scale and the Fatigue-Related Quality of Life (FACIT-F scale).
Before treatment commencement, and at 21 days, 43 days, and 90 days after.
Physical Condition Score
Délai: Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement

Karnofsky Performance Status、Eastern Cooperative Oncology Group Performance Status
Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
Emotional state
Délai: Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement

Anxiety levels will be assessed using the HADS-A scale, while depression levels will be evaluated using the HADS-D scale.
Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
progression-free survival，PFS
Délai: On days 43, 90, 133, 233, 365, 450 and 540 following the commencement of treatment.

Time from randomization to first radiographic tumor progression.
On days 43, 90, 133, 233, 365, 450 and 540 following the commencement of treatment.
Evaluation of Syndrome and Symptom Points of Traditional Chinese Medicine
Délai: Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement

The effective rate of Traditional Chinese Medicine syndromes = (number of markedly effective cases + number of effective cases) / total number of cases in the group × 100%.
Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
Assess the impact of lung disease on patients
Délai: Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement

Lung Cancer Subscale (FACT-L) - Lung Cancer-Specific Items and St. George's Respiratory Questionnaire (SGRQ)
Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
Tumor markers
Délai: Before treatment initiation, and on Days 43, 90, 133, 233, 365 , 450,and 540.

Includes commonly used tumor markers for small cell lung cancer: progastrin-releasing peptide (ProGRP) and neuron-specific enolase (NSE), as well as carcinoembryonic antigen (CEA).
Before treatment initiation, and on Days 43, 90, 133, 233, 365 , 450,and 540.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

LI FENG

Collaborateurs

Peking University Cancer Hospital & Institute
Beijing Chest Hospital, Capital Medical University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 janvier 2027

Achèvement primaire (Estimé)

31 décembre 2027

Achèvement de l'étude (Estimé)

31 décembre 2028

Dates d'inscription aux études

Première soumission

4 novembre 2026

Première soumission répondant aux critères de contrôle qualité

4 novembre 2026

Première publication (Réel)

10 novembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

10 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

4 novembre 2026

Dernière vérification

1 octobre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • SF2026-1-4022

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

The project involves some patents that will not be disclosed at this time.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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